Guided Imagery in the Perioperative Period in Gynecologic Oncology Patients

Not Applicable

Completed

• Conditions: Uterine Cervical Neoplasms; Fallopian Tube Neoplasms; Urogenital Neoplasms; Uterine Neoplasms; Ovarian Neoplasms

• Registration Number: NCT02444195
• Lead Sponsor: University of Michigan

Brief Summary

The purpose of this study is to evaluate the effectiveness of self-administered perioperative guided imagery to reduce perioperative distress in gynecologic oncology patients undergoing surgical management for a presumed cancer diagnosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-05-07
• Study First Submitted QC: 2015-05-11
• Study First Posted: 2015-05-14
• Primary Completion: 2016-05-01
• Study Completion: 2016-05-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-16
• Last Update Posted: 2017-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

• Undergoing surgical management for a suspected diagnosis of Gynecologic Malignancy (Endometrial, Ovarian, Vulvar, Vaginal, Primary Peritoneal, Fallopian Tube)
• Age 18 or greater
• Receiving care at University of Michigan Comprehensive Cancer Center Gynecologic Oncology Clinic or at St. Joseph Mercy Hospital, Alexander Cancer Care Center
• Able to understand and read English
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Patients must have working telephone, mobile or land line

Exclusion Criteria

• Severe hearing impairment that limits the ability to use audio-based guided imagery modules
• Current documented alcohol abuse or illicit drug substance abuse
• Planned outpatient surgery
• Patients currently participating in a meditation practice for more than 1 hour per week prior to preoperative visit.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Level of distress in the immediate postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument.	postoperative day 1
Level of distress in the delayed postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument.	6-8 week postoperative exam

Secondary Outcome Measures

Name	Time	Method
Level of distress, measured by questionnaire using the Hospital Anxiety and Depression Scale-total (HADS-T).	postoperative day 1 and 6-8 week postoperative exam
Effect of perioperative guided imagery on health care compliance, measured by the General Adherence Scale (GAS) survey.	6-8 week postoperative visit
The effect of perioperative guided imagery on hope, measured by the Adult Hope Scale (AHS) questionnaire.	postoperative day 1 and 6-8 week postoperative exam
Level of pain, measured by a 7-item questionnaire using a Likert numerical rating scale for pain	postoperative day 1 and 6-8 week postoperative exam
Perioperative analgesic use, measured by patient-completed usage log and hospital medical record.	postoperative day 1 and 6-8 week postoperative exam
Patient satisfaction regarding in hospital perioperative care, measured by a questionnaire adapted from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.	postoperative day 1 and 6-8 week postoperative exam
Effect of perioperative guided imagery on health care related locus of control, measured by the Multidimensional Health Locus of Control-form A (MHLC-A) questionnaire.	postoperative day 1 and 6-8 week postoperative exam
Level of anxiety and depressions, measured by questionnaire using the Hospital Anxiety and Depression Scale subscale for anxiety (HADS-A) and depression (HADS-D).	postoperative day 1 and 6-8 week postoperative exam

Trial Locations

Locations (1)

University of Michigan Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States